Pain management after inguinal hernia surgery
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Open Inguinal Herniorrhaphy
Run by Cali Pharmaceuticals LLC · NCT05813847 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if a local anaesthetic injection can help people feel less pain after inguinal hernia surgery compared to other treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 504 (estimated) |
| Sponsor | Cali Pharmaceuticals LLC Industry-sponsored |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT05813847 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy adults aged 18 to 75 who are scheduled for inguinal hernia repair and meet specific health criteria.
✕Probably not a fit
Patients with a history of inguinal hernia surgery or those with concurrent painful conditions requiring analgesics may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of a local anaesthetic injection (CPL-01) compared to a positive control and a negative control in managing postoperative pain following inguinal hernia repair. Participants will be monitored after receiving the treatment to assess pain levels and overall recovery. The study aims to determine if the local anaesthetic can provide better pain relief than the other control options. It is a Phase 3 interventional trial, indicating a focus on evaluating the treatment's efficacy in a larger patient population.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing inguinal hernia surgery.
How similar studies have gone: Other studies have shown promising results with local anaesthetic interventions for postoperative pain management, suggesting this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to sign Informed Consent * Scheduled to have inguinal hernia repair * Be a reasonably healthy adult 18 - 75 years of age * Body mass index ≤ 39 kg/m2 * If biologically female, not pregnant or planning to become pregnant * If biologically male, using acceptable birth control * Be willing and able to complete study procedures Exclusion Criteria: * Previously inguinal herniorrhaphy * Concurrent painful condition that may require analgesic treatment * History or clinical manifestation of significant medical, neuropsychiatric, or other condition, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation * Clinically significant existing arrhythmia, bundle branch block or abnormal ECG, myocardial infarction, or coronary arterial bypass graft surgery within the prior 12 months * History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency. * Impaired liver function (e.g., alanine aminotransferase \[ALT\] \> 3 × upper limit of normal \[ULN\] or total bilirubin \> 2 × ULN), active hepatic disease, or cirrhosis. * Impaired renal function (e.g., creatinine \> 1.5 × ULN). * Malignancy in the past year * Known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
Where it's running
-
Todd Bertoch
Salt Lake City, Utah, United States Recruiting
Study contacts
- Study coordinator: Erol Onel
- Email: e.onel@calibiosciences.com
- Phone: 2038376500
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Pneumoperitoneum time and bicarbonate changes during laparoscopic inguinal hernia repair
This study will see if longer pneumoperitoneum time during laparoscopic inguinal hernia repair causes changes in blood bicarbonate levels in adults.
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Quadro-iliac plane block versus TAP block for pain after inguinal hernia surgery
In adults undergoing unilateral inguinal hernia repair, this study tests whether the Quadro-iliac Plane Block provides better postoperative pain relief than the Transversus Abdominis Plane Block.
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Comparing mesh removal to no mesh removal for chronic groin pain after hernia repair
This study is testing whether taking out hernia mesh helps people with chronic groin pain feel better compared to not removing the mesh after their hernia repair.
-
Robotically repairing ventral or inguinal hernias using OviTex mesh
This study is testing whether using a special mesh called OviTex in robotic surgery can help people with ventral or inguinal hernias recover better and avoid complications.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.